Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000363583
Ethics application status
Approved
Date submitted
28/03/2015
Date registered
22/04/2015
Date last updated
22/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the use of a wheat dextrin fibre supplement improve bowel performance in patients on dialysis?
Scientific title
Does the use of a wheat dextrin fibre supplement reduce constipation compared to placebo in patients on renal dialysis?
Secondary ID [1] 286425 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation 294594 0
Kidney Failure 294669 0
Condition category
Condition code
Oral and Gastrointestinal 294972 294972 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Renal and Urogenital 294973 294973 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly assigned to receive a wheat dextrin fibre supplement or maltodextrin placebo for 4 weeks. After a 2 week washout period followed patients will then receive the opposite treatment to what they did in the first 4 weeks in a randomised crossover study.

Patients will increase their supplement use in the first week up to a maximum of 15 grams. This will be done by being instructed to take 6 grams in days 1-3, 12 grams during days 4-6 and 15 grams on day 7. A maximum of 15 grams will then be taken for the next 3 weeks. The same will occur with the placebo.

Both the wheat dextrin fibre supplement and the maltodextrin placebo disolve to be clear and tasteless in drinks and some foods. This is how the supplement will be instructed for patients to consume. All doses in the first week and following three weeks will be instructed to be taken as split doses over the day. For example, 15 grams is instructed to be taken as 9 grams in the morning and 6 grams in the evening.

Supplement will be supplied to patients in blank 1L screw top containers with a scoop inside. One flat scoop will measure exactly 3 grams of fibre supplement. For example, when taking 15 grams per day patients are instructed to take 3 scoops in the morning and 2 scoops in the evening.

Patients will be instructed to keep a record of how much supplement or placebo they take each day. They will also record their bowel habits and laxative use during the intervention period. Laxative use will be recorded to see if the dose taken can be reduced as the amount of supplement is increased.

Phone calls will be made to monitor adherence. These will be scheduled weekly for each patient during each period - Observation, treatment and placebo.
Intervention code [1] 291502 0
Treatment: Other
Comparator / control treatment
Maltodextrin as placebo. Used in the same way as wheat dextrin fibre supplement
Control group
Placebo

Outcomes
Primary outcome [1] 294651 0
Stool frequency as assessed by using the Bristol Stool Chart
Timepoint [1] 294651 0
Every time a stool is formed will be recorded during every stage of the study - 2 week observation stage, 4 week treatment stage and 4 week placebo stage
Primary outcome [2] 294725 0
Stool form as assessed by using the Bristol Stool Chart
Timepoint [2] 294725 0
Every time a stool is formed will be recorded during every stage of the study - 2 week observation stage, 4 week treatment stage and 4 week placebo stage
Secondary outcome [1] 313794 0
Laxative use using a patient held record sheet
Timepoint [1] 313794 0
Every time a laxatives are taken during every stage of the study - 2 week observation stage, 4 week treatment and 4 week placebo stage. This could be multiple times daily.
Secondary outcome [2] 313795 0
Quality of life using the Patient Assessment if Constipation Quality of Life 28 question form.
Timepoint [2] 313795 0
During the last day of each stage - Observation, treatment and placebo.

Eligibility
Key inclusion criteria
- Patient must be on peritoneal or haemodialysis
- Patients must be taking laxatives
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Those that do not take laxatives and that do not have constipation
- Those with dementia
- Those who have surgery scheduled in the next few months
- Those using opioids
- Those with coeliac disease
- Those already using wheat dextrin fibre supplement

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/04/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
31
Accrual to date
Final
Recruitment outside Australia
Country [1] 6780 0
New Zealand
State/province [1] 6780 0

Funding & Sponsors
Funding source category [1] 291006 0
University
Name [1] 291006 0
Massey University
Country [1] 291006 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Private Bag 102 904
School of Food and Nutrition
Massey University
Auckland
0745
Country
New Zealand
Secondary sponsor category [1] 289684 0
None
Name [1] 289684 0
Address [1] 289684 0
Country [1] 289684 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292592 0
Northern B Health and Disability Ethics Council
Ethics committee address [1] 292592 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 292592 0
New Zealand
Date submitted for ethics approval [1] 292592 0
Approval date [1] 292592 0
23/03/2015
Ethics approval number [1] 292592 0
15/NTB/46

Summary
Brief summary
The primary purpose of the study is to reduce constipation in patients on renal dialysis in the Northland Districy Health Board using a wheat dextrin fibre supplement. The hypothesis is that the use of a wheat dextrin fibre supplement will improve bowel performance, reduce laxative use and improve quality of life in renal dialysis patients in the Northland District Health Board.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55278 0
Mr Chester Edwards
Address 55278 0
Private Bag 102 904
School of Food and Nutrition
Massey University
Auckland
0745
Country 55278 0
New Zealand
Phone 55278 0
+64274905770
Fax 55278 0
Email 55278 0
[email protected]
Contact person for public queries
Name 55279 0
Chester Edwards
Address 55279 0
Private Bag 102 904
School of Food and Nutrition
Massey University
Auckland
0745
Country 55279 0
New Zealand
Phone 55279 0
+64274905770
Fax 55279 0
Email 55279 0
[email protected]
Contact person for scientific queries
Name 55280 0
Chester Edwards
Address 55280 0
Private Bag 102 904
School of Food and Nutrition
Massey University
Auckland
0745
Country 55280 0
New Zealand
Phone 55280 0
+64274905770
Fax 55280 0
Email 55280 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.